Pregnancy Complications from Herceptin, PERJETA, and KADCYLA

Herceptin: Taking Herceptin during pregnancy can result in reduced amniotic fluid (oligohydramnios), in some cases complicated by incomplete development of the lungs (pulmonary hypoplasia), and death of the newborn child. Please see the full Prescribing Information for Herceptin, including Boxed WARNINGS.

PERJETA: Exposure to PERJETA can result in embryo-fetal death and birth defects. Studies in animals have resulted in reduced amniotic fluid (oligohydramnios), delayed development of the kidneys, and death. Please see the full Prescribing Information for PERJETA, including Boxed WARNINGS.

KADCYLA: KADCYLA can cause harm to the unborn child when administered to a pregnant woman. There are no adequate and well-controlled studies of KADCYLA in pregnant women, and no reproductive and developmental toxicology studies have been conducted. Nevertheless, the two components of KADCYLA (trastuzumab and DM1) are known or suspected to cause fetal harm or death when given to a pregnant woman.

Treatment with trastuzumab, the antibody component of KADCYLA, during pregnancy in the postmarketing setting has resulted in reduced amniotic fluid (oligohydramnios), in some cases associated with fatal pulmonary hypoplasia, skeletal abnormalities, and death of the newborn child. DM1, the cytotoxic component of KADCYLA, can be expected to cause embryo-fetal toxicity based on how it works. Please see the full Prescribing Information for KADCYLA, including Boxed WARNINGS.

Contact Us to Start Enrollment

To start the enrollment process, you can contact the registry in the following ways:

Phone: 1-800-690-6720

Fax: 1-800-800-1052

Email:
pregnancyregistries@incresearch.com

Mailing Address:
The MotHER Pregnancy Registry
INC Research
301 Government Center Drive
Wilmington, NC 28401



Disclaimer

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Close

Thank you for submitting your email information.

A registry representative will be in touch with you to finalize enrollment details and respond to any question you may have.

Do I Need Authorization From My Patients ?

Do I Need Authorization From My Patients ?

This registry was required by the FDA and is exempt from HIPAA authorization requirements. Under 45 Code of Federal Regulations (CFR)-164.512(b)(1)(iii) of the HIPAA regulations, an authorization is not required for disclosure of health information for purposes related to the quality, safety, or effectiveness of an FDA-regulated therapy. This regulation applies to the MotHER Pregnancy Registry.

Informed consent (either verbal or written) is required. Healthcare professionals will not be able to enroll their patients without informed consent being obtained. They are allowed to review the ICF with their patients and then submit the signed document. The registry also requires medical releases to be able to contact any healthcare professional.

Need to fax forms to the registry?

Fax the registry at 1-800-800-1052.